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Regulatory Affairs Associate

Warsaw, Mazovia, Poland Date posted 09/09/2021 Job ID 66037BR

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.

Success Profile

Check out the top traits we're looking for and see if you have the right mix.

  • Detail-Oriented
  • Proactive
  • Problem-Solver
  • Results-Driven
  • Organized
  • Multi-Tasker
  • "When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."

    Chris – Associate Director, Regulatory & Access
  • "In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"

    Riley – Regulatory Affairs Consultant

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Management

    Strong management with depth of experience working for global health authorities.

Responsibilities

We are recruiting for a Regulatory Affairs Consultant to join our Clinical Trial Regulatory Services EU Consulting team in Poland .This is an ideal role for a Regulatory Leader who would excel working in a fast-paced international team. This is a 2 year contract initially.

German language skills are highly desirable but not essential for this role.


You will be responsible for:
- Acting as a local regulatory Lead for clinical trials in Poland and other european countries, you will be responsible for preparation and quality control of local regulatory submission packages for submissions to RAs to ensure regulatory compliance, accuracy and completeness.
- Acting as a regulatory lead managing the regulatory submission strategy and process worldwide throughout entire project life cycle, ensures global regulatory compliance and cross-functional communication.
- Providing regulatory consultancy and support for establishing the submission strategy for clinical trial application, response management, amendments and other maintenance submissions. Interacting with regulatory authorities, as required; liaise with internal and external partners on assigned projects.
- Preparation, review and approval of labels.
- Mentoring junior/new colleagues.

Qualifications

Skills:
• Regulatory Project management knowledge
• Excellent interpersonal and intercultural communication skills, both written and verbal
• Client-focused approach to work (Quality)
• Results orientation
• Teamwork and collaboration skills
• Consulting skills
• Critical thinking and problem-solving skills
• Proficiency in local language and extensive working knowledge of the English language

Knowledge and Experience:
• Several years of experience in an industry-related environment

Education:
• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred

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